[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pressure-ulcers-stage-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pressure-ulcers-stage-iii":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100623062","early-phase-1-efficacy-of-a-polyhexanide-biguanide-based-gel-in-the-prevention-of-biofilm-formation-in-pressure-ulcers-100623062",false,"NCT07391748","Efficacy of a Polyhexanide Biguanide-Based Gel in the Prevention of Biofilm Formation in Pressure Ulcers","EGELPUPP","Inclusion Criteria:\n\n* Bedridden patients, patients with bed-to-chair mobility, or those in a wheelchair.\n* Presenting one or more category II-III pressure ulcers.\n* Aged over 65 years.\n* Patients with laboratory results within normal metabolic values (HbA1c \\\u003C 7%).\n* Patients who, in item 6 \"infection\u002Fsuspected biofilm\" of the RESVECH 2.0 index, do not have tissue compatible with biofilm, hypergranulation, or purulent exudate, and never score more than 4 in the other items.\n* During follow-up, cases that develop signs and symptoms of local infection according to TILI and\u002For the RESVECH 2.0 index will be considered therapeutic failures, allowing for clinical rescue, but the patient will remain in the intention-to-treat (ITT) analysis.\n\nExclusion Criteria:\n\n* Patients who, despite the above, present a deteriorated health status that could influence the outcome, such as terminally ill patients, oncology patients, or those with inflammatory diseases.\n* Patients in a state of malnutrition according to the Mini Nutritional Assessment (MNA®) scale who are not receiving nutritional supplements, and\u002For at risk of malnutrition with nutritional deficits.\n* Patients with pressure ulcers in the perineal area and urinary incontinence (except those with a urinary catheter) and\u002For fecal incontinence.","ALL","65 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","INTRODUCTION: Pressure ulcers (PU) are one of the main challenges for nursing in our country. Wound bed preparation and the TIME algorithm provide essential tools for adequately treating these lesions. However, these wounds tend to become chronic due to the bacterial load in their bed. It is now known that bacteria can form complex and diverse structures, named as biofilm, which are difficult to diagnose and much more resistant to antimicrobial action.\n\nControlling these biofilms is crucial to create the optimal conditions for wound healing. Currently, it is believed that biofilms are present in 60-100% of chronic wounds. Therefore, more studies are needed to evaluate the efficacy of different antimicrobial agents on these structures.\n\nOBJECTIVE: To determine the efficacy of a gel containing polyhexanide and biguanide, alone or in combination with alginate with or without silver, in preventing biofilm in PU, in terms of healing at 4 weeks.\n\nMETHODOLOGY: Multicenter clinical trial with a 2x2 factorial design, conducted with patients from Alcoy with category II and III PUs that meet the inclusion and exclusion criteria. A sample of 140 participants is estimated, distributed into four groups of 35 patients. The interventions that will be carried out will be: application of Prontosan gel® and Aquacel Ag+®; Aquacel Ag+®; control group; Prontosan gel®. Data on wound evolution will be collected using RESVECH 2.0. Descriptive statistical analysis and hypothesis testing will be performed.",[26,27,28,29,30,31,32],"Pressure Ulcers","Pressure Ulcers Stage III","Pressure Ulcer Prevention","Pressure Ulcer ( Stage 2-3)","Biofilm Formation","Biofilm","Biofilm Removal",[34,35,36,37],"Pressure ulcers","biofilms","primary prevention","antimicrobial agents","NOT_YET_RECRUITING","2026-02-06",{"date":41,"type":42},"2026-02-10","ACTUAL",{"date":44,"type":20},"2026-01-30",{"date":46,"type":20},"2026-09-30",{"name":48,"class":49},"Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100477386","comparison-of-transforming-powder-dressing-to-npiap-recommended-standard-of-care-therapies-in-stage-2-3-and-4-pressure-injuries-100477386","NCT05496296","Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries","Randomized, Controlled, Open-Label, Parallel Group, Multi-Center, Prospective Phase 4 Study Comparing the Efficacy of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries","Inclusion Criteria:\n\n1. 18 to 85 years of age;\n2. Stage 2, 3, or 4 Pressure Injuries;\n3. Wound exudate is mild to moderate;\n4. No clinically active wound infection (clinical diagnosis);\n5. Able and willing to provide written (not proxy) informed consent;\n6. Clinically stable, as determined by assessment of medical history, vital signs, physical examination, and laboratory testing prior to enrollment.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to TPD or its components;\n2. Pressure injuries classified as unstageable, deep tissue pressure injury, or Stage 1;\n3. Heavily exudative wounds;\n4. Wound infection as defined as the presence of a least two of the following: local swelling or in duration, erythema \\>0.5cm around the ulcer in any direction, local tenderness or pain local warmth and purulent discharge;\n5. Poorly controlled diabetes with HgbA1C \\>12 (as documented in the last 3 months);\n6. Body Mass Index (BMI) \\>45 kg\u002Fm2;\n7. Venous stasis disease or lymphedema in the affected limb (if wound is located on the limb);\n8. Moderate to severe chronic limb ischemia Ankle Brachial Index (ABI) \\\u003C0.7 on the affected limb, if wound is located on the limb);\n9. Received immunosuppression or biologics in the last six weeks and\u002For is expected to receive either at any point during the study;\n10. Selected concurrent treatments (e.g., hyperbaric oxygen, topical oxygen therapy, electrical stimulation, ultrasound, cellular or acellular skin substitutes) during study period that may impact study outcomes;\n11. Wounds with necrosis unable to undergo prior definitive debridement;\n12. Fistulas;\n13. Active gangrene;\n14. Untreated HIV;\n15. Currently pregnant or lactating;\n16. Impending organ transplant;\n17. Vulnerable populations including prisoners, pediatrics, cognitively impaired, unconscious, and illiterate patients;\n18. Unwilling or unable to comply with offloading recommendations;\n19. If, in the opinion of the clinical investigator, a subject is a poor candidate for this study because:\n\n    1. Unable to keep research appointments;\n    2. Poorly controlled incontinence which may impact study outcomes (e.g., depending on the location of the wound);\n    3. Participated in another investigative study within 3 months of enrollment that could interfere with study outcomes;\n    4. Active alcohol or substance abuse (cocaine, heroin, or other substances) that may interfere with healing or subject compliance with visit schedules;\n    5. Concurrent clinical condition(s) that could pose a health risk to patient or influence outcome of study;\n    6. Not suitable for study participation. -",true,"18 Years","85 Years",{"count":61,"type":20},300,[63],"NA","Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue loss and exposed bone. This study will compare current standard of care treatment (as recommended by the National Pressure Injury Advisory Panel) to treatment with Altrazeal® in patients with stage 2, stage 3 and stage 4 pressure injury wounds. Altrazeal® is a Class 1, 501(k) exempt medical device listed with the FDA as a \"dressing, wound, hydrogel\" and has an extended wear time of up to 30 days. Subjects can be enrolled in the study either as an outpatient, or while hospitalized. Half of the subjects will be randomized to standard of care treatment, and the other half will be randomized to Altrazeal®. There are a total of up to 12 study visits taking place over 12 weeks.",[66,27,67],"Pressure Ulcers Stage II","Pressure Ulcer, Stage IV",[69,70,71],"Wound care","Quality of life","Pain","RECRUITING","2025-11-17",{"date":75,"type":42},"2025-11-20",{"date":77,"type":42},"2023-04-30",{"date":79,"type":20},"2026-12",{"name":81,"class":82},"ULURU Inc.","INDUSTRY",14]